Category: Medical Devices

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

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Govzilla 510k 101

510(k) 101

The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.

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How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

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